Elisabeth L.
Process Manager DSP MSAT Commercial
Experience
Process Manager DSP MSAT Commercial
- 1 year of experience as Process Manager DSP MSAT Commercial in change control and CPV
- document review
- product quality review
- batch record review
- CMC
- dossier modules 2.3 and 3
- change control
Ulm, Germany
Project Manager
- coordination, creation and handling of change control requests
- review of dossiers (Module 2.3 and Module 3)
- preparation of change notifications (variations)
- revision of product information texts (labelling)
- management and maintenance of document management systems
- conducting batch record review
- conducting product quality review
Biopharmaceutical Quality Assurance Specialist
- 4 years of experience as a biopharmaceutical quality assurance specialist in change control, batch record review, and Site RA
- document review
- product quality review
- batch record review
- CMC
- dossier modules 2.3 and 3
- change control
Regulatory Affairs Specialist
- 9 years of experience as a regulatory affairs specialist in dossier life cycle management, CMC and labelling
- document review
- product quality review
- batch record review
- CMC
- dossier modules 2.3 and 3
- change control
Summary
communication skills
detail-oriented work style
analytical thinking
problem-solving skills
adaptability and ability to prioritize
flexible
coordination, creation and handling of change control requests
review of dossiers (Module 2.3 and Module 3)
preparation of change notifications (variations)
revision of product information texts (labelling)
management and maintenance of document management systems
conducting batch record review
conducting product quality review
Languages
German
NativeEnglish
IntermediateEducation
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M.D.R.A. · Drug Regulatory Affairs
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Bachelor · Pharmaceutical Technology
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